Bioequivalence and Bioavailability Forum

Hi Kotu,

❝ 1. PASS

❝ 2. nQuery Advisor+ nTerim.

Both are fine. However, considering the subject line none (!) of them support sample size estimation for BE studies with reference-scaling. There is no explicit formula for power. Hence, Monte-Carlo simulations are required. You have essentially two options:

1. Use the package PowerTOST for R. This is what the authors of the sample size tables* recommend.
   
2. Code simulations in your software of choice. SAS is terribly slow (roughly by a factor of 1,000 com­pared to PowerTOST), MatLab is a little bit faster. I guess that C could perform similar to PowerTOST.

❝ Which soft ware is more reliable for regulatory agencies to construction of Sample size calculation for Clinical trials?

No idea. Be aware that the final responsibility concerning validation of software lies in your hands. Power­TOST contains sample size tables from the literature and test-scripts to support you in this task.

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• Endrényi L, Tóthfalusi L. Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs. J Pharm Pharmaceut Sci. 2011;15(1):73–84. online